NCT07412613
招募中
3 期
A Randomized, Open-label, Controlled, Multicenter Phase 3 Clinical Trial of AK104 for Neoadjuvant/Adjuvant Treatment of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
概览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Akeso
- 入组人数
- 386
- 试验地点
- 2
- 主要终点
- Event Free Survival (EFS)
概览
简要总结
This is a randomized, open-label, controlled, multicenter phase 3 study. All patients are resectable microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer. The purpose of this study is to evaluate the efficacy and safety of neoadjuvant/adjuvant treatment of AK104 (Cadonilimab) versus adjuvant chemotherapy in patients with resectable MSI-H/dMMR colon cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign a written ICF.
- •≥ 18, ≤ 75 years old at the time of enrollment, regardless of sex.
- •Eastern Cooperative Oncology Organization (ECOG) performance status score of 0 or
- •Life expectancy greater than 2 years.
- •Histologically confirmed primary colon adenocarcinoma (without squamous carcinoma or sarcomatoid components); colon is defined as ≥ 12cm from the anal verge by colonscopy.
- •Participants with resectable stage IIB-III colon cancer according to the AJCC 8th staging, as assessed by imaging (enhanced CT or enhanced MRI) .
- •Microsatellite instability detection demostrates MSI-H (with 5 NCI-recommended microsatellite detection sites: BAT25, BAT26, D5S346, D2S123, D17S250, or combinations of other guidelines and clinically recognized site) , or mismatch repair detection demostrates dMMR (evaluating the expression of 4 MMR proteins: MLH1, MSH2, MSH6, PMS2 by immunohistochemistry, and positive expression is localized to the nucleus).
- •Before enrollment, the participant needs to be evaluated by the responsible surgeon to confirm whether he/she is eligible for radical R0 resection, and does not require combined organ resection based on medical history.
- •Female participants of childbearing potential must have a urine or serum pregnancy test within 3 days before the first dose (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test is required, and the serum pregnancy result shall prevail), and the result is negative. If a female participant of childbearing potential has sex with a male partner who is not sterilized, the participant must use an acceptable method of contraception from screening and must agree to use a contraceptive method continuously until 120 days after the last dose of study drug; Contraception should be discussed with the investigator as to whether to discontinue contraception after this time point.
- •If a non-sterilized male participant has sex with a female partner of childbearing potential, the participant must take an effective method of contraception from the beginning of screening until 120 days after the last dose; Contraception should be discussed with the investigator as to whether to discontinue contraception after this time point.
排除标准
- •Previously received any anti-tumor treatment for the study disease, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
- •Previously (within 3 years) or currently suffering from other malignant tumors, except for cured local tumors (such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, etc.).
- •Participated in treatment with investigation drugs or used investigation devices within 4 weeks prior to randomization.
- •History of immunodeficiency; tested positive for HIV antibodies; currently on long-term systemic corticosteroids or other immunosuppressive agents.
- •Known active tuberculosis (TB); subjects suspected of having active TB need clinical examination for exclusion; known active syphilis infection.
- •Known history of allograft organ transplantation or allograft hematopoietic stem cell transplantation.
- •Previous history of pneumonitis/interstitial lung disease requiring systemic corticosteroid treatment or currently having pneumonitis.
- •Experiencing severe infection within 4 weeks prior to randomization, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; having received systemic anti-infection treatment for active infection within 2 weeks prior to randomization (excluding antiviral therapy for hepatitis B or hepatitis C).
- •Subjects with active hepatitis B (HBsAg positive and HBV-DNA over 1000 copies/ml (200 IU/ml) or above the lower limit of detection, whichever is higher). Note: Subjects with hepatitis B are required to receive antiviral treatment throughout the study.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
AK104
Experimental
Participants will receive AK104 before and after surgery
干预措施: Cadonilimab (AK104) (Drug)
Physician's choice of chemotherapy
Active Comparator
Participants will receive physician's choice of chemotherapy after surgery
干预措施: Capecitabine (Drug)
Physician's choice of chemotherapy
Active Comparator
Participants will receive physician's choice of chemotherapy after surgery
干预措施: 5- Fluorouracil (Drug)
Physician's choice of chemotherapy
Active Comparator
Participants will receive physician's choice of chemotherapy after surgery
干预措施: Calcium Folinate (Drug)
Physician's choice of chemotherapy
Active Comparator
Participants will receive physician's choice of chemotherapy after surgery
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Event Free Survival (EFS)
时间窗: Up to approximately 5 years
Time from randomization to disease progression, local or distant recurrence in post-surgery phase, or death due to any cause
Pathologic Complete Response (pCR) rate as assessed by investigator
时间窗: 1 month after surgery
Proportion of participants with post-surgery stage of ypT0N0 as assessed by investigator
次要结局
- Adverse event(Up to approximately 5 years)
- Overall Survival (OS)(Up to approximately 5 years)
- R0 resection rate(Up to approximately 2 years)
- Safety assessment(Up to approximately 5 years)
- Pharmacokinetics (PK)(Up to approximately 2 years)
- Anti-Drug Antibodies(ADAs)(Up to approximately 2 years)
研究者
研究点 (2)
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